MAUDE Adverse Event Report: UNKNOWN CONTACT LENS (UNKNOWN BRAND/MANUFACTURER); LENSES, SOFT CONTACT

Device Problem Off-Label Use (1494)

Patient Problems Dry Eye(s) (1814); Hypoxia (1918); No Code Available (3191)

Event Date 02/26/2020

Event Type  Injury  

Event Description

Patient received illegal non-illegal non-prescribed box of contact lenses from (b)(6) in (b)(6).She was given a pair of contact lenses based on her spectacle prescription and had no contact lens rx.The lenses she was given have resulted in severe dryness secondary to improper fitting contact lens due to tight lens syndrome and corneal hypoxia resulting in corneal neovascularization.These complications and decrease quality of life could have been avoided had the law been followed and patient had contact lenses that were prescribed by a doctor.

• Brand Name: CONTACT LENS (UNKNOWN BRAND/MANUFACTURER)
• Type of Device: LENSES, SOFT CONTACT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9775290
• MDR Text Key: 182138952
• Report Number: MW5093435
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 20 YR